The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma. In addition, researchers would like to determine if the drugs are most effective together or if fenretinide (4-HPR/LXS) is most effective alone.

Further study details as provided by South Plains Oncology Consortium:

Primary Outcome Measures:

Phase 2: Progression Free Survival [ Time Frame: From date of enrollment until date of documented progression or date of death (up to 48 months after last patient enters treatment) ] [ Designated as safety issue: No ]

The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.

Phase 2: Overall Survival [ Time Frame: From enrollment up to first date of progressive disease or death from any cause (up to 48 months after last patient entered treatment) ] [ Designated as safety issue: No ]

The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.

Phase 1: To determine the systemic toxicity profile of 4-HPR/LXS oral powder + ketoconazole [ Time Frame: From time of first dose to the last (average 6 months) ] [ Designated as safety issue: Yes ]

Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.

Phase 2: Event Free Survival [ Time Frame: From enrollment up to the first date of progressive disease or death from any cause (up to 48 months after last patient entered on treatment) ] [ Designated as safety issue: No ]

The objective response rate will be calculated as the percent of evaluable patients whose best response is a CR or PR, and assoicated exact 95% confidence intervals will be calculated. Time to treatment failure, duration of response and survival will be estimated using the product-limit method of Kaplan and Meier.

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: up to 48 months after the last subject enrolled ] [ Designated as safety issue: No ]

Area under the plasma concentration versus time curve (AUC) steady state plasma concentrations

In this study, an initial Phase I component of six patients will be conducted to monitor for potential toxicities as this wil be the initial adult experience of fenretinide (4-HPR) given together with ketoconazole

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Recurrent epithelial ovarian cancer or primary peritoneal carcinoma that can be platinum sensitive or platinum resistant

SWOG Performance Status 0-2

Previously received a platinum and paclitaxel containing regimen

Projected Life Expectancy of at least 3 months

Adequate bone marrow function

Adequate organ function

Must have received at least 1 prior salvage regimen for recurrent ovarian cancer

Recovery from acute toxicities from surgery, radiation or chemotherapy

Use of certain medications is prohibited - contact study coordinator for information

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535157